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Halitosis During Active Orthodontic Treatment

Primary Purpose

Halitosis

Status

Unknown status

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Manual Toothbrush

Dental floss

Waterjet

Electric Toothbrush

About this trial

This is an interventional prevention trial for Halitosis

Eligibility Criteria

14 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

participants with fixed orthodontic appliance.
participants age 14 years and above and didn't have mental of physical disabilities.
participants willing to comply with given oral hygiene instructions.

Exclusion Criteria:

patients with mental retardation.
patients with systematic diseases.

Sites / Locations

Riyadh Elm UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

ManualTB+Floss

ManualTB+Waterjet

Electric TB+Floss

Electric TB +Waterjet

Arm Description

Cleaning teeth with a manual toothbrush and a dental floss three times a day.

Cleaning teeth with a manual toothbrush and a waterjet three times a day.

Cleaning teeth with an electric toothbrush and dental floss three times a day .

Cleaning teeth with an electric toothbrush and a waterjet three times a day .

Outcomes

Primary Outcome Measures

Change in volatile sulphur compounds causing halitosis at four weeks.

Tanita Breath Checker HC-312SF Fitscan to measures volatile sulphur compounds with six levels of odor.

Change in volatile sulphur compounds causing halitosis at eight weeks.

Tanita Breath Checker HC-312SF Fitscan to measures volatile sulphur compounds with six levels of odor.

Secondary Outcome Measures

Full Information

NCT ID

NCT03901625

First Posted

April 1, 2019

Last Updated

April 1, 2019

Sponsor

Riyadh Colleges of Dentistry and Pharmacy

1. Study Identification

Unique Protocol Identification Number

NCT03901625

Brief Title

Halitosis During Active Orthodontic Treatment

Official Title

The Efficacy of Different Methods of Teeth Cleaning on the Levels of Volatile Sulfur Compounds in Patients With Orthodontic Fixed Appliances

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 13, 2018 (Actual)

Primary Completion Date

June 6, 2019 (Anticipated)

Study Completion Date

October 11, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Riyadh Colleges of Dentistry and Pharmacy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To determine the effect of different cleaning methods and devices in reducing halitosis during active orthodontic treatment.

Detailed Description

. Observer - blind clinical trial, randomly divided into four groups, A, B, C and D. each group will undergo clinical evaluation and oral malodor assessment and they will be assigned electric or manual toothbrushes with super floss or water floss respectively.clinical evaluation will include plaque index (PI), gingival bleeding index (GBI), bracket index.and halitosis will be measured by halimeter . Measurements and time frame: Initial measurements (T0), after two weeks (T1), and after four weeks (T2) ( according to previous studies that uses the same period of time for measurements),17, 18 plaque index (PI), gingival bleeding index (GBI), bracket index and halimeter reading . During the first week after the start of the study (T0)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Halitosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ManualTB+Floss

Arm Type

Active Comparator

Arm Description

Cleaning teeth with a manual toothbrush and a dental floss three times a day.

Arm Title

ManualTB+Waterjet

Arm Type

Experimental

Arm Description

Cleaning teeth with a manual toothbrush and a waterjet three times a day.

Arm Title

Electric TB+Floss

Arm Type

Experimental

Arm Description

Cleaning teeth with an electric toothbrush and dental floss three times a day .

Arm Title

Electric TB +Waterjet

Arm Type

Experimental

Arm Description

Cleaning teeth with an electric toothbrush and a waterjet three times a day .

Intervention Type

Device

Intervention Name(s)

Manual Toothbrush

Intervention Description

A manual toothbrush is used to clean teeth surfaces.

Intervention Type

Device

Intervention Name(s)

Dental floss

Intervention Description

A dental floss is used to clean inter-proximal areas.

Intervention Type

Device

Intervention Name(s)

Waterjet

Intervention Description

A waterjet is used to clean inter-proximal areas.

Intervention Type

Device

Intervention Name(s)

Electric Toothbrush

Intervention Description

An electric toothbrush is used to clean teeth surfaces.

Primary Outcome Measure Information:

Title

Change in volatile sulphur compounds causing halitosis at four weeks.

Description

Tanita Breath Checker HC-312SF Fitscan to measures volatile sulphur compounds with six levels of odor.

Time Frame

At baseline then and after four weeks then

Title

Change in volatile sulphur compounds causing halitosis at eight weeks.

Description

Tanita Breath Checker HC-312SF Fitscan to measures volatile sulphur compounds with six levels of odor.

Time Frame

At four weeks from baseline and after eight weeks then

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: participants with fixed orthodontic appliance. participants age 14 years and above and didn't have mental of physical disabilities. participants willing to comply with given oral hygiene instructions. Exclusion Criteria: patients with mental retardation. patients with systematic diseases.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Omar H AlKadhi, BDS, MSc

Phone

+966505154754

omar.alkadhi@riyadh.edu.sa

Facility Information:

Facility Name

Riyadh Elm University

City

Riyadh

State/Province

Ar Riyad

ZIP/Postal Code

11681

Country

Saudi Arabia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Omar AlKadhi

12. IPD Sharing Statement

Learn more about this trial

Halitosis During Active Orthodontic Treatment

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